Class II — Philips North America
| Recalling firm | Philips North America |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to software malfunction, patient information system may freeze and become unresponsive. |
| Product | Philips Patient Information Center iX REF:866389 |
| Quantity | 7359 Units |
| Distribution | Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Andorra, Utd. Arab. Emir., Argentina, Austria, Australia, Aruba, Bosnia-Herz., Bangladesh,… |
| Initiated | 2026-07-31 |
| Classified | 2026-09-11 |
| Recall number | Z-3141-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips North America (Z-3141-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99566/
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